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Blood Sparing Strategies: Omni-stat Routinary Use in Cardiac Surgery. A Prospective Randomized Study.

NCT01008436 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2012-02-22

No results posted yet for this study

Summary

The study enrolles all consecutive patients undergoing cardiac surgery at the European Hospital, Rome. The population undergoes randomization to receive usual surgical hemostasis or added topical application of Omni-stat Celox.

The two populations are followed up prospectively as regarding blood loss and need for blood transfusions, as well as adverse events at 30 days after surgery.

Conditions

  • Hemostasis

Interventions

DRUG

Omni-stat Celox

Topical administration of 6 gr of Omnistat Celox

DRUG

Control

Traditional surgical Hemostasis

Sponsors & Collaborators

  • Cardiochirurgia E.H.

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2010-08-31
Completion
2010-09-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01008436 on ClinicalTrials.gov